NCT07862569Not yet recruitingPhase 2
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Doravirine/Islatravir (100 mg/0.25 mg) in Pediatric Participants With HIV-1 Infection Who Are Virologically Suppressed or Treatment-Naïve, Are Less Than 18 Years of Age, and Weigh Greater Than or Equal to 35 kg
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) \[MK-8591A\] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are virologically suppressed or treatment-naive. The Base Study will last from Day 1 to Week 96. At Week 96, participants will be given the option to participate in an optional Study Extension and receive DOR/ISL until Week 240 or until it becomes commercially accessible, whichever is first.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- 23 Dec 2026
- Primary completion date
- 24 Sept 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT07862569
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 23 Dec 2026 to the primary completion date, 24 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hypsensitivity/contraindication to any components of study medication or as determined by the investigator
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
Other illness
- HIV-2 infection
- Has an active diagnosis of hepatitis due to any cause
Lab values
- Has a history or current evidence of any condition (including active tuberculosis infection, COVID-19, or other infections), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study
Age
- history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Who the study is looking for
- Pediatric participant with HIV-1 \<18 years of age
- Body weight ≥35 kg
- Is TN (HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL) or VS (HIV-1 positive at screening with plasma HIV-1 RNA \<50 copies/mL AND has received stable, continuous 2- or 3-drug antiretroviral therapy (ART) for ≥3 months prior to providing informed consent)
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.